pertagen Use In Pregnancy & Lactation

Pregnancy: Because of the potential benefits of maternal pertussis immunization and the lack of monovalent acellular pertussis vaccine in the USA, pregnant women should receive Tdap boosters during each pregnancy even though moderate to severe local reactions have been associated with high levels of tetanus and diphtheria antitoxin (WHO, 2014).
In a randomized controlled trial where 80 pregnant women were exposed to Boostagen TdaP_gen (Td vaccine combined to Pertagen aP_gen components) have shown a safety profile in mothers and foetus/newborns similar to the chemically-detoxified pertussis toxoid (Tdap_chem) comparator vaccine. In addition, safety data from active post-marketing surveillance (including a prospective observational study) where 1,778 pregnant women were exposed to Pertagen or Boostagen in the second or third trimester of pregnancy have shown no vaccine related adverse effect on pregnancy or the health of newborns.
No adverse effects on pregnancy, parturition, lactation or prenatal and postnatal development were observed in two reproductive and developmental animal toxicity studies evaluating Pertagen antigens combined to tetanus and diphtheria toxoid.
Lactation: No study on lactation was performed in humans. However, as Pertagen contains inactivated antigen, no risk to the breastfed infant should be expected.